Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis. (E02OSMAS0108)

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To evaluate the efficacy and tolerability of Auris-Sedina in the symptomatic control of otalgy in patients with and without acute external otitis compared with use of Otosynalar®.

Condition or disease

Intervention/treatment

Phase

OtitisEfficacyTolerability

Drug: Auris-SedinaDrug: Otosynalar®

Phase 3

Detailed Description:

Phase III open Study, multicenter, prospective, randomized entrance of a total of 188 patients, 94 patients will receive medication test and 94 patients will receive Otosynalar®.

Patients will be assessed until the clinical condition has been resolved or a maximum of 3 days.

188 patients of either gender or race, who have at least two of the following symptoms: pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo. And with a clinical or non-acute external otitis.

Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.

Drip 2 drops of the medication with the head tilted and protect with a cotton swab. Repeat the process one at a time until the pain relief. Continue the administration of medication every 3 hours until the pain ceases.

The medication should be used for a maximum of 3 days when they should return to the doctor.

Drug: Auris-Sedina

Drip 2 drops of the medication with the head tilted and protect with a cotton swab. Repeat the process one at a time until the pain relief. Continue the administration of medication every 3 hours until the pain ceases.

The medication should be used for a maximum of 3 days when they should return to the doctor.

Active Comparator: Otosynalar®

Drip 3 drops in the ear 2 times a day. The medication should be used by more than 3 days after which the patient must return to the doctor.

Drug: Otosynalar®

Drip 3 drops in the ear 2 times a day. The medication should be used by more than 3 days after which the patient must return to the doctor.

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Ages Eligible for Study:

6 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with otalgy or not, with acute external otitis ;

Patients with at least two symptoms of otalgy (pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo) with the Visual Analogic Scale score between 4 and 8 (mild to moderate);

The patient must present otalgia in one ear;

Children above 6 years of age;

Adults over 18 years of age;

Patients who consent to participate in the study;

Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test.

Exclusion Criteria:

Patients with sensitivity to any component of the formula;

Patients pregnant or lactating;

Non visualization of the tympanic membrane of obstruction by cerumen;

Patients with evidence of any wound or scratch on the ear (ulcerative lesion);

Patients who are making use of any other medication that might interfere with the evaluation of effectiveness of study (such as antibiotics, antiinflammatory, solutions ear);

Patients who have severe classification in the Visual Analogic Scale score 9 or 10 in any of the symptoms listed in the questionnaire;

Patients with otalgy not otological origin;

Patients with otitis, except acute external otitis ;

Patients who have epiglottitis;

The patient with infection;

Patients who can not follow the procedures clarified in this protocol.